Drug Serialization — Local Knowledge The Key To Protecting Patients In U.S. And International Markets

A Q&A with Ian Parsonage, Senior Director, Global Serialization Services, PCI Pharma Services

Evolving track-and-trace rules in key markets are driving pharmaceutical industry demand for adaptable contractors with regional expertise, according to Ian Parsonage, Senior Director, Global Serialization Services at PCI Pharma Services.

Beginning in late November 2017, pharmaceuticals sold in the U.S. must be marked with a National Drug Code (NDC), a serial number, a lot number, and an expiration date. The requirement, stipulated in 2013’s Drug Quality and Security Act (DQSA) (H.R. 3204), is designed to harmonize existing state-to-state variations in track-and-trace laws.

The idea is to eventually establish a nationwide tracking system to secure supply chains and accelerate the identification of substandard and counterfeit products. Another aim is to provide manufacturers with clear guidelines on how their products should be marked.

How effective the new laws will be remains to be seen, but what is certain is that drug makers that supply multiple countries will soon have another set of market-specific requirements with which to comply.

Evolving track-and-trace rules in key markets are driving pharmaceutical industry demand for adaptable contractors with regional expertise.

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Regional tRack-and-tRace vaRiationsMany countries — Argentina, India, South Korea, and Turkey, for example — have aligned their track-and-trace legislation with GS1 standards, which are a set of platform-independent guidelines designed to allow products to be tracked as they cross international borders.

The difficulty for globally active pharmaceutical firms is that other countries like China and Brazil have developed their own track-and-trace systems with market-specific rules.

In Europe the situation is also complex. Italy implemented a double bar code labeling system for pharmaceuticals in 2005. Greece followed suit with a different system in 2007, and Belgium also introduced the Ipex system (all three being adhesive label-based solutions). Turkey then introduced its own system in 2012.

The implementation of the 2011 Falsified Medicines Directive (FMD) in 2019/2025 is intended to harmonize European track-and-trace rules.

euRope and the u.s. But even after the FMD and DQSA are in place, companies that supply both markets will need to be aware of the differences in track-and-trace rules on each side of the Atlantic.

For example, in Europe, serialization data will be passed to a central database and then shared with national hubs. Pharmacists will be able to scan the bar codes to verify products are genuine and to check for any recalls. This is primarily considered as an authentication model.

In the U.S., the focus is on tracing drug products at every stage of their journey from manufacturing plant to pharmacy, sometimes referred to as pedigree. By 2023, the Drug Supply Chain Security Act (DSCSA) will require that serial numbers can be followed through every transaction in the supply chain. This is more of a track-and-trace or verification model.

expeRtise and flexibilityComplying with all these different rules requires expertise, according to Parsonage, who shared his thoughts on track-and-trace rules in the U.S., Europe, and emerging international markets.

How prepared are drug makers for the next stage of implementation of U.S. track-and-trace legislation in 2017?Parsonage: We have seen the entire spectrum. Some businesses have included advanced anti-counterfeit features for decades and these businesses tend to be leading the way for serialization too. What is more worrying is that although most companies have started looking at the systems they need for compliance with the regulations, a significant proportion — perhaps 30 percent — have not even started to prepare.

Companies have less time than they think. The average lead time for a serialization core system, which is the time between purchasing and installation/qualification, is usually three to four months. To specify, order, install and qualify a packaging line system can take up to 9 months. With only 21 months to the U.S. deadline, manufacturers have only a few more months to ensure they have chosen a system and then need to complete the install in order to ensure that all applicable product is serialized flowing into the supply chain by November 2017.

Drug Serialization — Local Knowledge The Key To Protecting Patients In U.S. And International Markets

We believe the market will rely heavily on expert CMOs to help meet the new U.S. requirements.

The other key consideration is that serialization systems are expensive. Buying and installing a site system, combined with the required hardware could be $300,000 to $500,000. A full line system can range between $400,000 and $1.3 million per line, which, for a manufacturer that operates several plants, can amount to a significant capital outlay.

For these reasons we believe the market will rely heavily on expert CMOs to help meet the new U.S. requirements, and we are ready to assist, both as a service provider and as a supply chain partner offering our expertise.

What about other markets?Parsonage: Most countries require the smallest salable unit of a pharmaceutical to be marked with some form of serial number. In some markets where track-and-trace requirements are aligned with GS1, product serialization compliance is relatively straightforward.

In markets that have developed their own unique country legislation, compliance is more of a challenge. China, for example, is a more complex market. The regulations require that a China National Drug Code number and a government-issued serial number are printed on the unit, bundle and case packaging levels of all applicable pharmaceutical products.

Similarly, Brazil has unique track-and-trace regulations. Whilst based upon GS1, ANVISA regulations originally mandated that a pharmaceutical product’s secondary packaging is marked with a 2D bar code that each stakeholder in the supply chain must log and transmit to the agency. This includes showing up to 6 lines of human readable data to include the ANVISA registry number. Brazil is currently undergoing a review of its serialization regulations and more clarifying information is expected to be released in the first half of 2016.

What impact have track-and-trace rules in countries outside the U.S. had on suppliers, and what has PCI learned from operating in such markets?Parsonage: Some established markets, and indeed some emerging markets, have been very successful at developing and implementing serialization programs by engaging in early dialogue with stakeholders. The approach really benefits those companies with global supplies, enabling them to get started with serialization at a manageable scale.

For PCI, having international operations has given us a broad overview of the global market, where products we package are sold in more than 100 countries. This knowledge allows us to ensure we have a consistent solution for each individual market need and client. Each country can have its own regulatory and market requirements, not only for serialization, but also for additional needs to be compliant. This can be a significant challenge for pharmaceutical companies to manage, which is often why they utilize PCI’s expertise.

With these regulatory differences in mind, how important is it that serialization systems are flexible? Parsonage: This depends on the range of packaging types used by the manufacturer. At PCI sites, for example, we use custom developed FlexSuiteTM systems that enable us to serialize a wide variety of packaging sizes, ranging from as small as a common matchbox to as large as a shoe box, engineered in response to customer needs.

We use a technology solution developed by Antares Vision at all of our sites. The platform combines data management technologies with production line equipment for serialization, verification, and data capture.

Drug Serialization — Local Knowledge The Key To Protecting Patients In U.S. And International Markets

Market specific regulatory requirements can vary significantly from country to country. The Brazilian market requires the 2D barcode, along with six lines of human readable text. Utilizing laser ablation technology, PCI serialization systems provide for codes to be applied and electronically verified on solid color panels including brand colors such as green.

A key benefit is the diversity of coding technologies that can be employed. We can use traditional inkjet, covert UV inkjet, or laser technologies, which are becoming increasingly popular.

Another factor is the amount of space available on the package. Although the amount of information required varies depending on the market, in general, most serial numbers need to contain between four and six lines of text that can be read by eye and electronically.

In addition, all our serialization operations are fully validated. The first step is to validate the equipment and the software used to manage and control the serialization data — both site and line level. Each packaging line is then validated for each product or family of products.

Finally, the interfaces between PCI’s ERP and serialization systems and our customers’ EPCIS systems are validated to make sure data can be exchanged securely and reliably.

What are the essentials for a serialization system for a contract manufacturing organization?Parsonage: Flexibility is fundamental. We have to be able to meet the differing needs of our clients, and one of the key benefits our platform offers is the ability to utilize the technology across many different product configurations.

The AntaresVision system allows us to change from one serialization program to another in less than a minute. In addition, we have stand-alone FlexSuiteTM-based lines that enable us to apply serialization to pre-packed drugs. This is important because it allows us to work with customers that are unable to implement serialization systems at their own packaging operations. PCI can receive partially- or fully-packaged products from manufacturers or other CMOs, serialize them, aggregate as needed and return back to the supply chain. We are seeing increasing demand for this service.

PCI has the flexibility to work with everyone from the largest pharmaceutical and biotech companies in the world to midsize companies as well as the modestly staffed startups. Our ability to share best practices across this spectrum of clients and markets is very powerful.

We try to identify the solution best suited to each client, depending on their needs. Some come to us with a distinct plan, while others want us to manage their data and rely on our expertise.

Are there any common challenges that all customers face irrespective of size? Parsonage: Some of our clients have clear ideas of the serialization operations or services they want. Others look for guidance. We are witnessing increasing demand in response to the new serialization regulations which go live in 2017/2019 in the U.S. and Europe.

Many drug companies do not appreciate the impact serialization regulations in key markets will have on their operations, and part of our job is to help them prepare.

Finally, does PCI have the capacity to cope with increasing demand?Parsonage: PCI has packaging facilities across North America and Europe that supply medicines to more than 100 countries. We aim to provide clients with on-demand capacity whether they are launching a new product in a new market, responding to spikes in demand, or switching manufacturing sites.

We are continually investing in serialization capacity expansion across our sites, which allows us to stay ahead of demand and maintain seamless supply continuity for our clients.

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PCI Pharma Services is an integrated full service provider, a proven and trusted partner to leading companies in the global healthcare industry. We offer unparalleled expertise and experience in taking compounds from the earliest stages of development through to successful commercialization, delivering speed-to-market and commercial success for our customers.

Our core services support each stage of the product lifecycle, including drug development, clinical trial supply, commercial launch and ongoing commercial supply. We partner with clients in providing innovative technologies, flexible solutions, and an integrated supply network supporting lifesaving medicines destined to over 100 countries around the world.

We support clients with a dedication to providing the industry’s leading experience, exemplified in our operational flexibility, delivery, and commitment to safety, supported by industry leading technologies and an exemplary quality and regulatory record. This has allowed us to be the partner of choice for leading pharmaceutical companies around the world, operating as a seamless extension of their business.

www.pciservices.com

Ian Parsonage leads the global serialization implementation team for PCI’s global supply network across North America and Europe for all delivery forms. Prior to joining the serialization initiative, he held the position of Head of Information Systems for PCI’s sites in the UK. Mr. Parsonage has an extensive history in information technology including Enterprise Resource Planning (ERP) implementation, global IT integration, and business planning applications.

Ian Parsonage,Senior Director,

Global Serialization Services,PCI Pharma Services

Drug Serialization — Local Knowledge The Key To Protecting Patients In U.S. And International Markets